INTRAVENOUS INJECTION SITE WITH SPLIT SEPTUM AND PRESSURE ACTIVATED FLOW CONTROL VALVE

• US 20070225648A1
• Filed: 03/24/2006
• Published: 09/27/2007
• Est. Priority Date: 03/24/2006
• Status: Active Grant

• Current Assignee: Nexus Medical LLC (Garmin Limited)
• Original Assignee: Nexus Medical LLC (Garmin Limited)
• Inventors: Winsor, Chris, Smith, Larry, Dikeman, W.
• Granted Patent: US 8,211,089 B2
• Time in Patent Office: Days
• US Class Current: 604/167.40
• CPC Class Codes: A61M 2039/1027 Quick-acting type connectors
• CPC Class Codes: A61M 2039/1072 with a septum present in the connector
• CPC Class Codes: A61M 2039/242 designed to open when a predetermined pressure or flow rate has been reached, e.g. check valve actuated by fluid
• CPC Class Codes: A61M 2039/2426 Slit valve
• CPC Class Codes: A61M 39/045 pre-slit to be pierced by blunt instrument
• CPC Class Codes: A61M 39/10 Tube connectors; Tube couplings A61M39/02 takes precedence; connecting needles to syringes or hubs A61M5/34; connecting catheter tubes to hubs A61M25/0014
• CPC Class Codes: A61M 39/24 Check- or non-return valves
• CPC Class Codes: A61M 39/26 Valves closing automatically on disconnecting the line and opening on reconnection thereof check valves A61M39/24
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

An improved injection site (12) for infusion of parenteral fluids and the like is provided, having a pressure-actuated valve (20) and a novel split septum unit (24), which effectively prevent reflux of blood into the assembly (10). The septum unit (24) includes a resilient split septum body (64) which is precompressed so that the septum body (64) is caused to protrude proximally (78) upon insertion of a cannula (16). Consequently, upon removal of the cannula (16), there is essentially no “drumming” or creation of friction-induced negative pressures sufficient to generate blood reflux. The preloaded septum body (64) also has its proximal surface (74) essentially flush and coplanar with the adjacent proximal end (66b) of the tubular septum holder (66) to enhance the cleanliness of the unit (24). The specialized well (46) and septum unit (24) afford a resilient seal between the periphery of the septum body (64) and the surface (50), and a separate hard-surface seal between the outer margin of the surface (50) and the septum holder (66).

Claims

1. An intravenous injection site for connection to a cannula, said injection site comprising:

a split septum unit including a resilient septum body, wherein the body presents opposite proximal and distal faces and a slit extending therebetween to receive the cannula;

a pressure-actuated flow control valve spaced distally from the septum body and being operable to selectively prevent fluid flow in a proximal direction; and

a septum support assembly operable to precompress the septum body so that, upon insertion of the cannula, the septum body is displaced proximally to a greater degree than the septum body is displaced distally.

2. The intravenous injection site as claimed in claim 1,

said septum support assembly including an annular septum-engaging surface that presents a flow-through passageway,

said septum-engaging surface contacting the distal face of the septum body and thereby restricting distal displacement of the septum body when the cannula is inserted therein.

3. The intravenous injection site as claimed in claim 2,

said septum-engaging surface having a convex shape that projects proximally relative to the septum body,

said septum-engaging surface serving to precompress the septum body prior to the cannula being inserted therein.

4. The intravenous injection site as claimed in claim 3,

said flow-through passageway being centrally located and presenting a diameter between about 0.099 of an inch and about 0.112 of an inch.

5. The intravenous injection site as claimed in claim 3,

said septum-engaging surface presenting an outer periphery and a proximally spaced central apex,

said periphery and said apex being spaced apart approximately 0.026 of an inch.

6. The intravenous injection site as claimed in claim 5,

said flow-through passageway being located at the apex and presenting a diameter between about 0.099 of an inch and about 0.112 of an inch.

7. The intravenous injection site a claimed in claim 3,

said septum unit including a septum holder disposed about the septum body, said septum holder forming at least in part the septum support assembly.

8. The intravenous injection site as claimed in claim 7;

and

a support body supporting the septum unit and thereby forming in part the septum support assembly,

said support body including a well in which the septum unit is received, with connection structure being provided between the well and the septum holder to precompress the septum body prior to the cannula being inserted in the septum body.

9. The intravenous injection site as claimed in claim 8,

said connection structure comprising a groove formed in one of the well and the septum holder and a detent formed in the other of the well and the septum holder, with the groove receiving the detent.

10. The intravenous injection site as claimed in claim 1,

said valve preventing fluid flow in the proximal direction when fluid pressure differential across the valve is below a predetermined amount

11. The intravenous injection site as claimed in claim 10;

a support body supporting the septum unit and thereby forming at least in part the septum support assembly; and

a luer lock fitting fixed to the support body,

said valve being captured between the support body and the luer lock fitting.

12. The intravenous injection site as claimed in claim 1,

said split septum unit including a septum holder disposed about the septum body;

and

a support body supporting the split septum unit and including a septum well receiving the septum unit therein, with a first seal being defined between the bodies and a second seal being defined between the septum holder and the support body,

said septum holder and said support body each forming in part the septum support assembly.

13. The intravenous injection site as claimed in claim 1,

said septum support assembly presenting a terminal proximal face,

said proximal faces of the septum support assembly and the septum body being substantially flush to cooperatively present a substantially smooth swabable proximal surface.

14. An intravenous injection site for connection to a cannula, said injection site comprising:

a split septum unit including a resilient septum body, wherein the body presents opposite proximal and distal faces and a slit extending therebetween to receive the cannula; and

a support body supporting the split septum unit,

said support body including an annular septum-engaging surface that presents a flow-through passageway,

said septum-engaging surface contacting the distal face of the septum body and thereby restricting distal displacement of the septum body when the cannula is inserted therein.

15. The intravenous injection site as claimed in claim 14,

said septum-engaging surface having a convex shape that projects proximally relative to the septum body,

said septum-engaging surface serving to precompress the septum body prior to the cannula being inserted therein.

16. The intravenous injection site as claimed in claim 15,

said flow-through passageway being centrally located and presenting a diameter between about 0.099 of an inch and about 0.112 of an inch.

17. The intravenous injection site as claimed in claim 15,

said septum-engaging surface presenting an outer periphery and a proximally spaced central apex,

said periphery and said apex being spaced apart approximately 0.026 of an inch.

18. The intravenous injection site as claimed in claim 17,

said flow-through passageway being located at the apex and presenting a diameter between about 0.099 of an inch and about 0.112 of an inch.

19. The intravenous injection site as claimed in claim 15,

said septum body being precompressed so that, upon insertion of the cannula, the resilient body is displaced proximally to a greater degree than the septum body is displaced distally.

20. The intravenous injection site a claimed in claim 15,

said septum unit including a septum holder disposed about the septum body

said support body including a well in which the septum unit is received, with connection structure being provided between the well and the septum holder to precompress the septum body prior to the cannula being inserted in the septum body.

21. The intravenous injection site as claimed in claim 20,

said connection structure comprising a groove formed in one of the well and the septum holder and a detent formed in the other of the well and the septum holder, with the groove receiving the detent.

22. The intravenous injection site as claimed in claim 14;

and

a pressure-actuated flow control valve spaced distally from the septum body and being operable to selectively prevent fluid flow in a proximal direction.

23. The intravenous injection site as claimed in claim 22,

said valve preventing fluid flow in the proximal direction when fluid pressure differential across the valve is below a predetermined amount

24. The intravenous injection site as claimed in claim 23;

and

a luer lock fitting fixed to the support body,

said valve being captured between the support body and the luer lock fitting.

25. The intravenous injection site as claimed in claim 14,

said split septum unit including a septum holder disposed about the septum body,

said support body including a septum well receiving the septum unit therein, with a first seal being defined between the bodies and a second seal being defined between the septum holder and the support body.

26. The intravenous injection site as claimed in claim 14,

said split septum unit including a septum holder disposed about the septum body,

said support body including a septum well receiving the septum unit therein,

said septum holder presenting a terminal proximal face,

said proximal faces of the septum holder assembly and the septum body being substantially flush to cooperatively present a substantially smooth swabable proximal surface.

27. The intravenous injection site as claimed in claim 26,

said septum holder projecting proximally outward from the support body, such that the swabable proximal surface is spaced from the support body.

28. An intravenous injection site for connection to a cannula, said injection site comprising:

a split septum unit including a resilient septum body, wherein the body presents opposite proximal and distal faces and a slit extending therebetween to receive the cannula,

said split septum unit including a septum holder disposed about the septum body; and

a support body supporting the split septum unit and including a septum well receiving the septum unit therein, with a first seal being defined between the bodies and a second seal being defined between the septum holder and the support body.

29. The intravenous injection site as claimed in claim 28,

said support body including an annular septum-engaging surface that presents a flow-through passageway,

said septum-engaging surface contacting the distal face of the septum body and thereby restricting distal displacement of the septum body when the cannula is inserted therein,

said septum-engaging surface having a convex shape that projects proximally relative to the septum body,

said septum-engaging surface serving to precompress the septum body prior to the cannula being inserted therein.

30. The intravenous injection site as claimed in claim 29,

said flow-through passageway being centrally located and presenting a diameter between about 0.099 of an inch and about 0.112 of an inch.

31. The intravenous injection site as claimed in claim 29,

said septum-engaging surface presenting an outer periphery and a proximally spaced central apex,

said periphery and said apex being spaced apart approximately 0.026 of an inch.

32. The intravenous injection site as claimed in claim 31,

said flow-through passageway being located at the apex and presenting a diameter between about 0.099 of an inch and about 0.112 of an inch.

33. The intravenous injection site as claimed in claim 29,

said septum body being precompressed so that, upon insertion of the cannula, the resilient body is displaced proximally to a greater degree than the septum body is displaced distally.

34. The intravenous injection site a claimed in claim 29,

said septum holder and well being provided with connection structure operable to precompress the septum body prior to the cannula being inserted in the septum body.

35. The intravenous injection site as claimed in claim 34,

said connection structure comprising a groove formed in one of the well and the septum holder and a detent formed in the other of the well and the septum holder, with the groove receiving the detent.

36. The intravenous injection site as claimed in claim 28;

and

a pressure-actuated flow control valve spaced distally from the septum body and being operable to selectively prevent fluid flow in a proximal direction.

37. The intravenous injection site as claimed in claim 36,

said valve preventing fluid flow in the proximal direction when fluid pressure differential across the valve is below a predetermined amount

38. The intravenous injection site as claimed in claim 37;

and

a luer lock fitting fixed to the support body,

said valve being captured between the support body and the luer lock fitting.

39. The intravenous injection site as claimed in claim 28,

said septum holder presenting a terminal proximal face,

said proximal faces of the septum holder and the septum body being substantially flush to cooperatively present a substantially smooth swabable proximal surface.

40. The intravenous injection site as claimed in claim 39,

said septum holder projecting proximally outward from the support body, such that the swabable proximal surface is spaced from the support body.

41. An intravenous injection site for connection to a cannula, said injection site comprising:

a split septum unit including a resilient septum body, wherein the body presents opposite proximal and distal faces and a slit extending therebetween to receive the cannula; and

a septum support assembly presenting a terminal proximal face,

said proximal faces of the septum support assembly and the septum body being substantially flush to cooperatively present a substantially smooth swabable proximal surface.

42. The intravenous injection site as claimed in claim 41,

said proximal faces of the septum support assembly and the septum body lying substantially in a common plane so that the swabable proximal surface is generally planar.

43. The intravenous injection site as claimed in claim 41,

said septum support assembly precompressing the septum body prior to insertion of the cannula.

44. The intravenous injection site as claimed in claim 43,

said septum body being precompressed by the support assembly, such that the septum body is displaced proximally to a greater degree than the septum body is displaced distally upon insertion of the cannula.

45. The intravenous injection site as claimed in claim 41,

said septum support assembly including an annular septum-engaging surface that presents a flow-through passageway,

said septum-engaging surface contacting the distal face of the septum body and thereby restricting distal displacement of the septum body when the cannula is inserted therein.

46. The intravenous injection site as claimed in claim 45,

said septum-engaging surface having a convex shape that projects proximally relative to the septum body,

said septum-engaging surface serving to precompress the septum body prior to the cannula being inserted therein.

47. The intravenous injection site as claimed in claim 46,

said flow-through passageway being centrally located and presenting a diameter between about 0.099 of an inch and about 0.112 of an inch.

48. The intravenous injection site as claimed in claim 46,

said septum-engaging surface presenting an outer periphery and a proximally spaced central apex,

said periphery and said apex being spaced apart approximately 0.026 of an inch.

49. The intravenous injection site as claimed in claim 48,

said flow-through passageway being located at the apex and presenting a diameter between about 0.099 of an inch and about 0.112 of an inch.

50. The intravenous injection site a claimed in claim 46,

said septum unit including a septum holder disposed about the septum body, said septum holder forming at least in part the septum support assembly.

51. The intravenous injection site as claimed in claim 50;

and

a support body supporting the septum unit and thereby forming in part the septum support assembly,

said support body including a well in which the septum unit is received, with connection structure being provided between the well and the septum holder to precompress the septum body prior to the cannula being inserted in the septum body.

52. The intravenous injection site as claimed in claim 51,

said septum holder projecting proximally outward from the support body, such that the swabable proximal surface is spaced from the support body.

53. The intravenous injection site as claimed in claim 51,

said connection structure comprising a groove formed in one of the well and the septum holder and a detent formed in the other of the well and the septum holder, with the groove receiving the detent.

54. The intravenous injection site as claimed in claim 41;

and

a pressure-actuated flow control valve spaced distally from the septum body and being operable to selectively prevent fluid flow in a proximal direction.

55. The intravenous injection site as claimed in claim 54,

said valve preventing fluid flow in the proximal direction when fluid pressure differential across the valve is below a predetermined amount

56. The intravenous injection site as claimed in claim 54;

a support body supporting the septum unit and thereby forming at least in part the septum support assembly; and

a luer lock fitting fixed to the support body,

said valve being captured between the support body and the luer lock fitting.

57. The intravenous injection site as claimed in claim 41,

said split septum unit including a septum holder disposed about the septum body;

and

a support body supporting the split septum unit and including a septum well receiving the septum unit therein, with a first seal being defined between the bodies and a second seal being defined between the septum holder and the support body,

said septum holder and said support body each forming in part the septum support assembly.